Inspector I

Job Description

Position Summary

The Inspector I will be responsible for the performance of entry level inspection, repetitive tasks associated with visual inspections and basic functional testing knowledge. Ensure company products are in compliance with internal and external specifications by performing a variety of routine and non-routine inspections and evaluations.

Essential Duties & Responsibilities

• Perform accurate mechanical, physical and visual inspections of raw materials, components, and sub-assemblies as per inspection plans and specification requirements.
• Follow all procedural requirements in the area of responsibility in order to maintain compliance to applicable Quality System Regulations (i.e.: cGMP compliance).
• Support the paper document archival process including preparation as well as the scanning of Documents for electronic archival.
• Initiate Non-Conformance reports as required.
• Supports NC and CAPA activities as needed.
• Work on special projects as they may arise.

Knowledge and Skills

• Basic computer skills in order to regularly access and document information.
• Must have basic written and oral communication skills adequate to communicate with other team members, understand verbal instructions, and read and comprehend written work instructions including words and engineering drawings.
• Ability to perform inspection tasks using microscopes, calipers and micrometers. Ability to complete 10-15 inspections.
• Demonstrated knowledge of medical device regulations and FDA regulatory standards preferred.

Minimum Qualifications, Education and Experience

• High School graduate or GED equivalent. AA or Technical Degree preferred.
• Must be 18 years of age.

Work Environment

• Must be able to perform essential job functions in an office environment.
• Long periods of sitting to enter/ analyze data is expected.
• Must have adequate manual dexterity to operate standard office equipment.
• Must be able to occasionally lift objects up to 25 lbs.
• Typically requires travel less than 5% of the time.